Details for New Drug Application (NDA): 213611
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NDA 213611 describes SACUBITRIL AND VALSARTAN, which is a drug marketed by Alembic, Alkem Labs Ltd, Biocon Pharma, Crystal, Dr Reddys, Hetero Labs Ltd Iii, Laurus, Lupin, Macleods Pharms Ltd, MSN, Novugen Pharma Sdn, Torrent, and Zydus Pharms, and is included in thirteen NDAs. It is available from twenty suppliers. Additional details are available on the SACUBITRIL AND VALSARTAN profile page.
The generic ingredient in SACUBITRIL AND VALSARTAN is sacubitril; valsartan. There are eleven drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the sacubitril; valsartan profile page.
The generic ingredient in SACUBITRIL AND VALSARTAN is sacubitril; valsartan. There are eleven drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the sacubitril; valsartan profile page.
Summary for 213611
| Tradename: | SACUBITRIL AND VALSARTAN |
| Applicant: | Novugen Pharma Sdn |
| Ingredient: | sacubitril; valsartan |
| Patents: | 0 |
Pharmacology for NDA: 213611
| Mechanism of Action | Angiotensin 2 Receptor Antagonists Neprilysin Inhibitors |
Suppliers and Packaging for NDA: 213611
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| SACUBITRIL AND VALSARTAN | sacubitril; valsartan | TABLET;ORAL | 213611 | ANDA | Novugen Pharma (USA) LLC | 82293-027 | 82293-027-10 | 60 TABLET, FILM COATED in 1 BOTTLE (82293-027-10) |
| SACUBITRIL AND VALSARTAN | sacubitril; valsartan | TABLET;ORAL | 213611 | ANDA | Novugen Pharma (USA) LLC | 82293-027 | 82293-027-20 | 180 TABLET, FILM COATED in 1 BOTTLE (82293-027-20) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 24MG;26MG | ||||
| Approval Date: | Jul 16, 2025 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 49MG;51MG | ||||
| Approval Date: | Jul 16, 2025 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 97MG;103MG | ||||
| Approval Date: | Jul 16, 2025 | TE: | AB | RLD: | No | ||||
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